Electrical stimulation method for reduction of joint compression

ABSTRACT

An electrical stimulation method for the reduction of joint compression is disclosed. In a preferred embodiment, the method utilizes an electrical stimulation device that includes a plurality of channels of electrodes each of which includes at least a first and second electrode positioned in electrical contact with tissue of at least two muscles crossing a joint. Agonist/antagonist muscles involved in abduction/adduction, flexion/extension, supination/pronation, protraction/retraction, and/or eversion/inversion of body regions via joint movement are stimulated with a patterned series of electrical pulses through channels of electrodes in accordance with a procedure for reducing joint compression. The patterned series of electrical pulses may comprise: a plurality of cycles of a biphasic sequential pulse train pattern; a plurality of cycles of a biphasic overlapping pulse train pattern; a plurality of cycles of a triphasic sequential pulse train pattern; and a plurality of cycles of a triphasic overlapping pulse train pattern.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and is a continuation of U.S. patentapplication Ser. No. 12/487,431, filed on Jun. 18, 2009, which claimsthe benefit of U.S. Provisional Patent Application Ser. No. 61/073,653,filed on Jun. 18, 2008, each of which is incorporated herein byreference in its entirety.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable.

FIELD OF THE INVENTION

The present invention is generally directed to a method for reducingjoint compression, and is more specifically directed to an electricalstimulation method for applying a patterned series of electrical pulsesto a plurality of channels of electrodes in accordance with a procedurefor reducing joint compression. The method results in improved muscleand nerve timing, which reduces co-activation of muscles associated withjoints during movement or during stabilization.

DESCRIPTION OF RELATED ART

The junction of two or more bones or skeletal parts is a joint. Thereare several types of human joints including fibrous (non-movable),cartilaginous (connected entirely by cartilage), and synovial joints. Asynovial joint is a freely movable articulation, in which contiguousbone surfaces are covered with collagenous fibrovascular tissue composedof flattened or cuboidal cells. The collagenous fibrovascular tissue iscalled articular cartilage. Examples of human synovial joints includethe elbow, shoulder, wrist, ankle, knee, hip, and intervertebral joints.

In a healthy human synovial joint, a synovial membrane surrounds thearticular cartilage and contains synovial fluid. Synovial fluid isnormally clear, resembling egg white. Synovial fluid lubricates thejoint by providing a thin liquid layer over the articular cartilage. Thesynovial fluid also carries oxygen and nutrients to the articularcartilage by diffusing into the spaces in the articular cartilage duringnon-movement. During movement, the synovial fluid is squeezed out of thearticular cartilage to maintain the surface liquid layer for lubricationand carry waste away from the articular cartilage. When the joint is atrest again, the synovial fluid diffuses back into the articularcartilage carrying with it a supply of nutrients and oxygen that itobtained from the increased blood flow around the joint during movement.The health of the articular cartilage is dependent upon the extrusionand diffusion of the synovial fluid normally caused by joint movement.

A common form of joint pain and/or stiffness arises from the unwantedco-contraction of muscles. The simultaneous contraction of an antagonistmuscle and its corresponding agonist muscle is termed “co-contraction”.The co-contraction causes joint compression, which results in thedegeneration or “wear and tear” of articular cartilage and is usuallyaccompanied by an overgrowth of bone, narrowing of the joint space,sclerosis or hardening of bone at the joint surface, and deformity injoints. Weight bearing joints, such as the knees and hips, areparticularly susceptible to osteoarthritis.

Unwanted involuntary muscle co-contraction, as a response to an abnormalstimulus such as pain during joint movement, can be destructive to thejoint over time. Sustained co-contraction increases the local level ofnorepinephrine. Norepinephrine causes vasoconstriction, which decreasesblood flow. Decreased blood flow prevents the synovial fluid frompicking up oxygen and nutrients to carry back to the articularcartilage. In addition to decreasing blood flow, sustainedco-contraction of opposing muscle groups has a net effect of increasingthe compressive force across the joint. The constant increasedcompressive force squeezes the synovial fluid out of the articularcartilage and prevents it from diffusing back in thereby starving thearticular cartilage of oxygen and nutrients. The starved articularcartilage deteriorates, which leads to additional pain, decreasedcoordination, increased joint stiffness, and eventual total jointdegeneration.

Carroll et al., U.S. Patent Application 2004/0054379 teaches the use ofsurface electrical simulation for increasing the quality and quantity ofsynovial fluid in joints. The patent emphasizes that the electricalsimulation is that which “mimics normal electrical sequencing ofsurrounding muscles of the joint during normal functioning activity.”See Para 0016. Thus, Carroll utilizes a functional sequence which causesthe joint to move.

BRIEF SUMMARY OF THE INVENTION

The present invention is directed to an electrical stimulation methodfor reducing joint compression in a patient by decreasing the unwantedco-contraction of agonist/antagonist muscle pairs associated with ajoint. In general, the electrical stimulation method utilizes anelectronic control unit connected to two or more channels of electrodes,such as transcutaneous or percutaneous electrodes. Each channelcomprises at least two electrodes (i.e., at least one relative positiveelectrode and at least one relative negative electrode), wherein oneelectrode is positioned in electrical contact with a first tissue of afirst muscle of a target joint of a patient and the other electrode ispositioned in electrical contact with a second tissue of a second muscleof a target joint of a patient. The electrical control unit applies aseries of electrical pulses having a biphasic or triphasic pattern tothe patient through the two or more channels of electrodes in accordancewith a procedure for reducing joint compression in the patient.

In one aspect, the electrical stimulation method stimulates the sensoryand motor nerves of the patient's musculature associated with opposingjoint movement. For example, electrodes can be positioned bilaterally orin electrical contact with the tissue of agonist/antagonist muscle pairsin the neck, trunk, shoulder, arm, wrist, hand, hip, thigh, lower leg,ankle, and foot of the patient that are associated with a joint.Examples of agonist/antagonist muscle pairs include abductors/adductors,flexors/extensors, supinators/pronators, protractors/retractors, andevertors/inverters. For example, both the flexor carpi radialis andflexor carpi ulnaris are flexors of the wrist. The extensor carpiradialis longus, in conjunction with extensor carpi radialis brevis, isan extensor of the wrist.

In a first embodiment, the electrical stimulation method can be used tostimulate the muscles associated with the cervical intervertebraljoints. For example, the electrodes are positioned in electrical contactwith tissue to stimulate a motor point of a patient's trapezius muscleand cervical paraspinal muscles.

In a second embodiment, the electrical stimulation method can be used tostimulate the muscles associated with the lower cervical and upperthoracic intervertebral joints. For example, the electrodes arepositioned in electrical contact with tissue to stimulate a motor pointof a patient's trapezius muscle and cervical and/or thoracic paraspinalmuscles.

In a third embodiment, the electrical stimulation method can be used tostimulate the muscles associated with the upper thoracic intervertebraljoints. For example, the electrodes are positioned in electrical contactwith tissue to stimulate a motor point of a patient's trapezius muscle,erector spinae muscle, and thoracic paraspinal muscles.

In a fourth embodiment, the electrical stimulation method can be used tostimulate the muscles associated with the lower thoracic and lumbarintervertebral joints. For example, the electrodes are positioned inelectrical contact with tissue to stimulate a motor point of a patient'slower thoracic and lumbar paraspinal muscles and abdominal muscles.

In a fifth embodiment, the electrical stimulation method can be used tostimulate the muscles associated with the lower thoracic and lumbarintervertebral joints. For example, the electrodes are positioned inelectrical contact with tissue to stimulate a motor point of a patient'smultifidus muscle and abdominal muscles.

In a sixth embodiment, the electrical stimulation method can be used tostimulate the muscles associated with the elbow joint. For example, theelectrodes are positioned in electrical contact with tissue to stimulatea motor point of a patient's biceps brachii muscle and triceps brachiimuscle.

In a seventh embodiment, the electrical stimulation method can be usedto stimulate the muscles associated with the shoulder joint. Forexample, the electrodes are positioned in electrical contact with tissueto stimulate a motor point of a patient's biceps brachii, pectoralismajor, anterior deltoid, triceps brachii, infraspinatus teres minor, andposterior deltoid muscles.

In an eighth embodiment, the electrical stimulation method can be usedto stimulate the muscles associated with the shoulder and elbow joints.For example, the electrodes are positioned in electrical contact withtissue to stimulate a motor point of a patient's biceps brachii muscle,anterior deltoid muscle, triceps brachii muscle, and posterior deltoidmuscle.

In a ninth embodiment, the electrical stimulation method can be used tostimulate the muscles associated with the wrist joint. For example, theelectrodes are positioned in electrical contact with tissue to stimulatea motor point of a patient's flexor digitorum superficialis muscle,flexor carpi radialis muscle, flexor carpi ulnaris muscle, extensordigitorum muscle, pollicis muscle, extensor digiti minimi muscle,extensor carpi ulnaris muscle, extensor carpi radialis longus muscle,and/or carpi radialis brevis muscle.

In a tenth embodiment, the electrical stimulation method can be used tostimulate the muscles associated with the wrist and elbow joints. Forexample, the electrodes are positioned in electrical contact with tissueto stimulate a motor point of a patient's biceps brachii muscle, tricepsbrachii muscle, intrinsic hand muscles, and/or extensor muscles of theforearm.

In an eleventh embodiment, the electrical stimulation method can be usedto stimulate the muscles associated with the ankle joint. For example,the electrodes are positioned in electrical contact with tissue tostimulate a motor point of a patient's extensor digitorum brevis muscle,tibialis anterior muscle, extensor digitorum longus muscle, extensorhallucis longus muscle, posterior tibialis muscle, flexor hallucismuscle, and/or intrinsic foot muscles including abductor hallucismuscle.

In a twelfth embodiment, the electrical stimulation method can be usedto stimulate the muscles associated with the ankle joint. For example,the electrodes are positioned in electrical contact with tissue tostimulate a motor point of a patient's tibialis anterior muscle, tricepssurae muscle group including gastrocnemius and soleus muscles, and/oranterior and lateral muscles of the leg including the peroneus muscle.

In a thirteenth embodiment, the electrical stimulation method can beused to stimulate the muscles associated with the knee joint. Forexample, the electrodes are positioned in electrical contact with tissueto stimulate a motor point of a patient's tibialis anterior, quadriceps,triceps surae, and/or hamstring muscles.

In a fourteenth embodiment, the electrical stimulation method can beused to stimulate the muscles associated with the hip and knee joints.For example, the electrodes are positioned in electrical contact withtissue to stimulate a motor point of a patient's quadriceps musclegroup, vastus medialis muscle, gluteus medius muscle, gluteus minimusmuscle, gluteus maximus muscle, tensor faciae latae muscle, hamstringmuscle group including biceps femoris muscle, semitendinosus muscle,and/or semimembraneous muscle, adductor magnus muscle, adductor longusmuscle, adductor brevis muscle, and medial hamstring muscles.

In a fifteenth embodiment, the electrical stimulation method can be usedto stimulate the muscles associated with the knee joint. For example,the electrodes are positioned in electrical contact with tissue tostimulate a motor point of a patient's rectus femoris muscle, vastuslateralis muscle, vastus medialis muscle, biceps femoris muscle,semimembranosus muscle and/or semitendinosus muscle.

In yet a sixteenth embodiment, the electrical stimulation can be used tostimulate the muscles associated with the knee joint. For example, thefirst pair of electrodes are generally positioned on the patient's skinon the vastus medialis and upper quadricep, and the second pair ispositioned on the hamstring and triceps surae muscles.

The series of electrical pulses applied to the one or more channels ofelectrodes may comprise a variety of different types of biphasic ortriphasic pulse train patterns. For example, a plurality of cycles of abiphasic sequential or overlapping pulse train pattern may be used, inwhich a first phase of electrical pulses is applied to a first channelof electrodes, and a second phase of electrical pulses is applied to asecond channel of electrodes. Using the biphasic sequential pulse trainpattern, the second phase of electrical pulses commences aftertermination of the first phase of electrical pulses such that there is atime delay there between. Using the biphasic overlapping pulse trainpattern, the second phase of electrical pulses commences beforetermination of the first phase of electrical pulses such that there isan overlap there between.

In another example, a plurality of cycles of a triphasic sequential oroverlapping pulse train pattern may be used, in which a first phase ofelectrical pulses is applied to a first channel of electrodes, a secondphase of electrical pulses is applied to a second channel of electrodes,and a third phase of electrical pulses is applied to the first channelof electrodes. Using the triphasic sequential pulse train pattern, thesecond phase of electrical pulses commences after termination of thefirst phase of electrical pulses such that there is a time delay therebetween, and, similarly, the third phase of electrical pulses commencesafter termination of the second phase of electrical pulses such thatthere is a time delay there between. Using the triphasic overlappingpulse train pattern, the second phase of electrical pulses commencesbefore termination of the first phase of electrical pulses such thatthere is an overlap there between, and, similarly, the third phase ofelectrical pulses commences before termination of the second phase ofelectrical pulses such that there is an overlap there between.

In one aspect of the present invention, reduction of joint compressionis shown by decreased co-contraction in opposing muscle groupsassociated with a joint as measured by muscle hardness and/orelectromyography (“EMG”) patterns. EMG is a technique for evaluating andrecording the electrical activity of muscles at rest and whilecontracting. An electromyograph is used to produce an electromyogram,which is a graphic record of the electrical potential generated bymuscle cells at rest and during contraction plotted over time. At rest,normal muscle tissue is electrically inactive. During contraction,normal muscle tissue is electrically active and produces actionpotentials that appear as peaks on the electromyogram. The electricalactivity of multiple muscles can be tracked in relation to one anotherusing EMG. When the EMG pattern for multiple muscles (agonist andantagonist) are compared, the length of time the action potential peaksoverlap indicates the length of muscle co-contraction. In a preferredaspect, the EMG is integrated (“I-EMG”) using commercially availablehardware or software. The raw EMG signal is preferably rectified andintegrated at a sample rate of 100-1000 Hz. The resulting data is thendisplayed as a value plotted on a graph.

A signal's frequency can be calculated in several possible ways,including via Fourier (and more easily implemented fast Fouriertransform (“FFT”)) transforms, measuring signal amplitude after bandpass filtering, and via half waves. Thus, in another aspect, thereduction of joint compression is shown by decreased co-contraction inopposing muscle groups associated with a joint (agonist and antagonist)as measured by muscle hardness and/or FFT patterns. Higher meanfrequencies and frequency spectrums indicates that the muscle is firingharder.

In another aspect of the present invention, reduction in jointcompression is shown by decreased hypertonia measured using a tissuehardness and compliance measurement device. Hypertonia is abnormalincreased muscle tone. Hypertonia of opposing muscles across a jointduring movement or non-movement indicates joint compression. A tissuehardness and compliance measurement device typically comprises a metalprobe approximately 1 cm² in area surrounded by a metal or plasticsleeve approximately 5 cm in diameter. Using a downward pressure, anexaminer pushes the blunt metal probe perpendicular to the surface ofthe skin overlying the muscle to be tested. For example, compliance andtone of the right quadriceps femoris muscle can be measured by placingthe tissue hardness and compliance measurement device above the rightsuperior border of the patella at the thigh center line while a patientis seated. The probe does not penetrate the skin and only a lightpressure by the examiner is needed. The tissue hardness and compliancemeasurement device measures the amount of deformation that occurs withinthe muscle (millimeter deflection) to a given unit of force. Musclemillimeter deflection can be measured when the muscle is relaxed toobtain a base-line muscle tone and compliance measurement. Musclemillimeter deflection can also be measured when the muscle is at varyinglevels of contraction. Varying levels of muscle contraction can berepeatedly obtained using a dynamometer. The higher the tone within themuscle, the less muscle millimeter deflection per unit of force. Muscletone increases with the level of muscle contraction.

The electrical stimulation methods for reducing joint compression of thepresent invention are well-adapted to be used with other conventionaltherapies for overall joint health, including, but not limited to:implementing a supervised exercise program involving low-impactactivities such as walking, swimming, and cycling; maintaining an idealbody weight; rest periods; applications of heat and cold; applicationsof light or lasers, application of pulsed and continuous magneticfields, applications of electrical stimulation for pain control,nonsteroidal anti-inflammatory drugs (NSAIDS) or analgesics such asacetaminophen, ibuprofen, naproxen, or aspirin; tramadol; codeine;propoxyphene; glucosamine; chondroitin sulfate; salicylates; Cox-2NSAIDS; surface application of capsaicin cream 0.25%; intra-articularinjections of steroids, corticosteroids, or hyaluronic acidpreparations; bracing, splinting, or orthotic treatments; and surgeryincluding joint replacement and arthroscopic procedures.

Additional aspects of the invention, together with the advantages andnovel features appurtenant thereto, will be set forth in part in thedescription which follows, and in part will become apparent to thoseskilled in the art upon examination of the following, or may be learnedfrom the practice of the invention. The objects and advantages of theinvention may be realized and attained by means of the instrumentalitiesand combinations particularly pointed out in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be described in greater detail in thefollowing detailed description of the invention with reference to theaccompanying drawings that form a part hereof, in which:

FIG. 1 is a block diagram of an electrical stimulation device that maybe used in accordance with the method of the present invention;

FIG. 2A is a timing diagram of a biphasic sequential pulse train patternthat may be applied to the output channels of the electrical stimulationdevice of FIG. 1;

FIG. 2B is a timing diagram of a biphasic overlapping pulse trainpattern that may be applied to the output channels of the electricalstimulation device of FIG. 1;

FIG. 2C is a timing diagram of a triphasic sequential pulse trainpattern that may be applied to the output channels of the electricalstimulation device of FIG. 1;

FIG. 2D is a timing diagram of a triphasic overlapping pulse trainpattern that may be applied to the output channels of the electricalstimulation device of FIG. 1;

FIG. 3A illustrates a method for treating joint compression in a patientby applying electrical stimulation in accordance with a first exemplaryembodiment of the present invention;

FIG. 3B illustrates a method for treating joint compression in a patientby applying electrical stimulation in accordance with a second exemplaryembodiment of the present invention;

FIG. 3C illustrates a method for treating joint compression in a patientby applying electrical stimulation in accordance with a third exemplaryembodiment of the present invention;

FIG. 3D illustrates a method for treating joint compression in a patientby applying electrical stimulation in accordance with a fourth exemplaryembodiment of the present invention;

FIG. 3E illustrates a method for treating joint compression in a patientby applying electrical stimulation in accordance with a fifth exemplaryembodiment of the present invention;

FIG. 3F illustrates a method for treating joint compression in a patientby applying electrical stimulation in accordance with a sixth exemplaryembodiment of the present invention;

FIG. 3G illustrates a method for treating joint compression in a patientby applying electrical stimulation in accordance with a seventhexemplary embodiment of the present invention; and

FIG. 3H illustrates a method for treating joint compression in a patientby applying electrical stimulation in accordance with an eighthexemplary embodiment of the present invention.

FIG. 3I illustrates a method for treating joint compression in a patientby applying electrical stimulation in accordance with a ninth exemplaryembodiment of the present invention.

FIG. 3J illustrates a method for treating joint compression in a patientby applying electrical stimulation in accordance with a tenth exemplaryembodiment of the present invention.

FIG. 3K illustrates a method for treating joint compression in a patientby applying electrical stimulation in accordance with an eleventhexemplary embodiment of the present invention.

FIG. 3L illustrates a method for treating joint compression in a patientby applying electrical stimulation in accordance with a twelfthexemplary embodiment of the present invention.

FIG. 3M illustrates a method for treating joint compression in a patientby applying electrical stimulation in accordance with a thirteenthexemplary embodiment of the present invention.

FIG. 3N illustrates a method for treating joint compression in a patientby applying electrical stimulation in accordance with a fourteenthexemplary embodiment of the present invention.

FIG. 3O illustrates a method for treating joint compression in a patientby applying electrical stimulation in accordance with a fifteenthexemplary embodiment of the present invention.

FIG. 3P illustrates a method for treating joint compression in a patientby applying electrical stimulation in accordance with a sixteenthexemplary embodiment of the present invention.

FIG. 4 illustrates the correlation between muscle hardness and the I-EMGratio. The Spearman's correlation coefficient was R=0.618, p<0.01, N=14.This demonstrates that the measurement of muscle hardness is directlycorrelated to the I-EMG ratio between the agonist and antagonistmuscles.

FIG. 5 illustrates the relationship between muscle hardness and the FFTratio. The Spearman's correlation coefficient was R=0.447, p<0.01, N=14.This demonstrates that the measurement of muscle hardness is directlycorrelated to the FFT ratio between the agonist and antagonist muscles.

FIG. 6 illustrates the relationship between the FTT ratio and the I-EMGratio. The Spearman's correlation coefficient was R=0.466, p<0.01, N=14.This demonstrates that the FFT ratio is directly correlated to the I-EMGratio between the agonist and antagonist muscles.

FIGS. 7A and 7B show the Visual Analog Scores of the five patients whoreceived patterned neuromuscular stimulation as described in Example 2.FIG. 7A shows the patients' pain level, while FIG. 7B illustrates thepatients' reported overall condition

FIG. 8 illustrates the results of the Western Ontario MacMaster 3.1(WOMAC) tests performed on the five patients from Example 2.

FIGS. 9 and 10 show the muscle strength of each patient throughout thecourse of treatment for the quadriceps, and hamstrings respectively forthe five patients in Example 2.

FIGS. 11A, 11B and 11C show the results of a “stand-up” test performedby the patients from Example 2. In FIG. 11A, the immediate effect of thepatterned neuromuscular electrical stimulation is shown by the patients;VAS pain level. FIG. 11B illustrates the amount of time it took tocomplete the test for each patient. In FIG. 11C, the amount of time ittook to complete the test was reported over the entire 24-week treatmentcourse.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENT

The present invention is directed to an electrical stimulation methodfor reducing joint compression.

As used herein, the term “administration” refers to a method of givingan agent to a patient, where the method is, e.g., topical, oral,intravenous, transdermal, intraperitoneal, or intramuscular. Thepreferred method of administration can vary depending on variousfactors, e.g., the components of the pharmaceutical composition.

As used herein, “concurrent administration,” “co-administration,” or“co-treatment” includes administration of the agents or application ofthe electrical stimulation treatment method together, or before or aftereach other. The therapeutic agents co-administered with the electricalstimulation treatment methods may be administered by the same ordifferent routes.

The phrase “pharmaceutically acceptable” is employed herein to refer tothose compounds, materials, compositions, and/or dosage forms which are,within the scope of sound medical judgment, suitable for use in contactwith the tissues of human beings and animals without excessive toxicity,irritation, allergic response, or other problem or complication,commensurate with a reasonable benefit/risk ratio.

The phrase “therapeutically effective amount” as used herein, means thatamount of an active agent which, alone or in combination with otherdrugs, provides a therapeutic benefit in the prevention, treatment, ormanagement of joint compression. Different therapeutically effectiveamounts may be readily determined by those of ordinary skill in the art.

As used herein, the term “electrical stimulation” refers to the passingof various types of current to a patient through transcutaneous orpercutaneous electrodes, and includes muscle activation by stimulationof the nerves innervating the sensory (cutaneous and position sensors)and muscle fibers associated with central pattern generator inputs orinhibitory mechanism and stimulation of motor efferent fibers whichactivate the muscles. The electrical stimulation used in the presentinvention is provided in a biphasic or triphasic pattern.

As used herein, the term “motor point” refers to an area of tissue thatcan be electrically stimulated by lower levels of electricity comparedto surrounding areas. The motor point overlies the innervated zone of amuscle where the motor nerve endings are concentrated or where the nervetrunk enters the muscle. The motor point is often used as a placementsite for surface electrodes used to stimulate the muscle.

As used herein, the term “tissue” refers to an aggregation ofmorphologically similar cells and associated intercellular matter actingtogether to perform one or more specific functions in the body,including epithelial, connective, muscle, and neural tissue.

As used herein, the term “treatment” refers to the treatment forreducing joint compression, in a patient, such as a mammal (particularlya human), which includes decreasing the length and intensity ofco-contraction of opposing muscle groups associated with a joint asdemonstrated by I-EMG, FFT, a combination thereof, or measuring muscletone.

As used herein, the term “agonist muscle” broadly refers to a musclethat is resisted or counteracted by another muscle, the “antagonistmuscle.” Examples of agonist/antagonist muscle pairs includeabductors/adductors, flexors/extensors, supinators/pronators,protractors/retractors, and evertors/inverters.

As used herein, the term “abductors” refers to muscles that generallycause movement away from the body centerline while “adductors” aremuscles that generally cause movement toward the body centerline.

As used herein, the term “flexors” refers to muscles that generallyreduce the angle of a joint, while “extensors” refers to muscles thatincrease the angle of the joint. For example, both the flexor carpiradialis and flexor carpi ulnaris are flexors of the wrist. The extensorcarpi radialis longus, in conjunction with extensor carpi radialisbrevis, is an extensor of the wrist.

As used herein, the term “pronator” refers to a muscle that causes thetwisting movement of the wrist that turns the palm from facing front tofacing back. The opposing movement, which turns the palm from facingback to facing front, is directed by a “supinator.”

As used herein, the term “protractor” is a muscle that moves a part ofthe body anterior in the horizontal plane while a “retractor” muscle isinvolved in the reverse movement.

As used herein, the term “evertor” refers to a muscle involved in thetwisting motion of the foot that turns the sole outward while theopposite movement of turning the sole inward is performed by an“inverter” muscle.

Referring to FIG. 1, an exemplary embodiment of an electricalstimulation device that may be used in accordance with the method of thepresent invention is designated generally as reference numeral 10.Electrical stimulation device 10 generally comprises an electroniccontrol unit 12 with a plurality of output connectors 14, 16, which areconnected to a plurality of output cables 18, 20 and associatedelectrode pairs 18 a, 18 b, and 20 a, 20 b, respectively.

Although two output connectors 14, 16 are shown in FIG. 1, it should beunderstood that electronic control unit 12 may include any number ofoutput connectors (such as one, two, six, or eight output connectors) inaccordance with the present invention.

Output cables 18, 20 each comprise any suitable type of insulatedconductive cable, such as a coaxial cable. In the illustratedembodiment, output cable 18 includes a back section 22 with a connector24 (such as a male jack) that attaches to output connector 14, and afront section 26 that splits into a first split end 26 a and a secondsplit end 26 b. Similarly, output cable 20 includes a back section 28with a connector 30 (such as a male jack) that attaches to outputconnector 16, and a front section 32 that splits into a first split end32 a and a second split end 32 b. Of course, it should be understoodthat each of the output cables 18, 20 could alternatively bemanufactured out of two separate leads (instead of having a frontsection with split ends). In addition, output cables 18, 20 could beconnected directly to electronic control unit 12 without the use ofconnectors.

As can be seen in FIG. 1, electrodes 18 a, 18 b are attached to splitends 26 a, 26 b of output cable 18, respectively. Similarly, electrodes20 a, 20 b are attached to split ends 32 a, 32 b of output cable 20,respectively. As such, output cable 18 and electrodes 18 a, 18 btogether form a first output channel (referred to hereinafter as“channel A”), and output cable 20 and electrodes 20 a, 20 b togetherform a second output channel (referred to hereinafter as “channel B”).Although two channels are shown in FIG. 1, it should be understood thatany number of channels (e.g., four, six, or eight channels) may be usedin accordance with the present invention (provided, of course, that thenumber of channels corresponds to the number of output connectors ofelectronic control unit 12).

In the illustrated example, electrodes 18 a and 20 a each comprise arelative positive electrode, and electrodes 18 b and 20 b each comprisea relative negative electrode. As will be described in greater detailherein below, each of the electrical pulses applied to electrodes 18 a,18 b and electrodes 20 a, 20 b may comprise, for example, a monophasicwaveform (which has absolute polarity), a biphasic asymmetric waveform(which has relative polarity), or a biphasic symmetric waveform (whichhas no polarity). Thus, as used herein, the term “positive electrode”refers to a relative positive electrode and the term “negativeelectrode” refers to a relative negative electrode (regardless ofwhether the electrical pulse comprises a monophasic waveform, anasymmetric biphasic waveform, or a symmetric biphasic waveform whichbehaves like the relative positive or relative negative electrode duringeach phase of the waveform).

Electrodes 18 a, 18 b and 20 a, 20 b are each adapted to be positionedin electrical conduct with tissue of selected regions of a patient, aswill be described in greater detail herein below with reference to FIG.3A-3H. In the illustrated embodiment, each of electrodes 18 a, 18 b and20 a, 20 b comprises a transcutaneous electrode having a surfaceelectrode pad that may be placed on the skin of a patient. As is knownin the art, each of electrodes 18 a, 18 b, and 20 a, 20 b may be formedof metal or some other physiologically acceptable conductive materialand may take on a variety of different sizes and shapes. Of course, oneor more of electrodes 18 a, 18 b and 20 a, 20 b may alternativelycomprise a percutaneous electrode, such as a needle electrode, or anyother type of suitable electrode in accordance with the presentinvention.

Electronic control unit 12 also includes internal circuitry (not shown)for selectively generating a series of electrical pulses in accordancewith a procedure for treating joint compression. The series ofelectrical pulses generated by the circuitry are provided at outputconnectors 14, 16 and, as such, may be applied to a patient throughchannel A and/or channel B. The series of electrical pulses may comprisea variety of different types of pulse train patterns, such as: aplurality of cycles of a biphasic sequential pulse train pattern; aplurality of cycles of a biphasic overlapping pulse train pattern; aplurality of cycles of a triphasic sequential pulse train pattern; or aplurality of cycles of a triphasic overlapping pulse train pattern. Eachof these pulse train patterns will be described in detail herein belowwith reference to FIGS. 2A-2D. One skilled in the art will understandthat a variety of different circuit configurations may be used togenerate the various pulse train patterns, such as the circuitrydescribed in Palermo, U.S. Pat. No. 5,562,718, which is incorporatedherein by reference.

A variety of different electrical stimulation devices may be used and/oradapted for use in accordance with the present invention. For example,one may incorporate the protocols disclosed herein into the Omnistim®FX² patterned electrical neuromuscular stimulator or the Omnistim® FX²Pro patterned electrical neuromuscular stimulator, both of which arecommercially available from Accelerated Care Plus, 4850 Joule Street,Suite A-1, Reno, Nev. 89502. Of course, other types of electricalstimulation devices could also be used, which are generally available inthe industry.

Referring now to FIGS. 2A-2D, examples of the various types of pulsetrain patterns that may be used in accordance with the present inventionwill now be described herein below. Preferably each pulse train patternhas a duration of 60 milliseconds to 200 milliseconds. The stimulationis timed such that there is a delay between pulse train patterns of 400milliseconds to 1200 milliseconds. The delay is short enough not tocreate a startle response in the muscle and long enough to providesufficient muscle relaxation and recovery. Preferably, the pulse trainpattern is applied to the patient for a total treatment time ofapproximately 10 minutes to 60 minutes (and most preferably about 20minutes to 30 minutes), as desired for a particular treatment.

Each of the pulse train patterns is comprised of a series of individualelectrical pulses arranged into a particular pattern. Each of theelectrical pulses may comprise either a monophasic or biphasic waveform,which may be, for example, asymmetric, symmetric, square, sinusoidal,and the like. Preferably, each of the electrical pulses comprises abiphasic asymmetric square wave having a pulse duration that rangesbetween 30 microseconds and 100 microseconds during the positive phaseand a current amplitude that typically ranges between 25 milliamps and140 milliamps.

Biphasic Sequential Pulse Train Pattern

Referring to FIG. 2A, electrical stimulation device 10 may be used toapply a plurality of cycles of a biphasic sequential pulse train patternto a patient. In a typical biphasic sequential pulse train pattern, afirst phase of electrical pulses is applied to channel A and a secondphase of electrical pulses is applied to channel B with a delay periodthere between.

In the illustrated example, the first phase of electrical pulses isapplied to channel A for approximately 60 milliseconds to 120milliseconds (and most preferably about 100 milliseconds). At theconclusion of the first phase of electrical pulses, there is a delayperiod of approximately 0 milliseconds to 100 milliseconds (and mostpreferably about 80 milliseconds) before the second phase of electricalpulses is applied to channel B. Then, the second phase of electricalpulses is applied to channel B for approximately 60 milliseconds to 120milliseconds (and most preferably about 100 milliseconds). The frequencyof the individual electrical pulses in each phase is approximately 30 Hzto 100 Hz (and most preferably about 50 Hz).

Biphasic Overlapping Pulse Train Pattern

Referring to FIG. 2B, electrical stimulation device 10 may also be usedto apply a plurality of cycles of a biphasic overlapping pulse trainpattern to a patient. In a typical biphasic overlapping pulse trainpattern, a first phase of electrical pulses is applied to channel A anda second phase of electrical pulses is applied to channel B with anoverlap there between.

In the illustrated example, the first phase of electrical pulses isapplied to channel A for approximately 60 milliseconds to 120milliseconds (and most preferably about 100 milliseconds). When thefirst phase of electrical pulses has reached a time period of between 40milliseconds and 100 milliseconds (and most preferably about 80milliseconds), the second phase of electrical pulses is applied tochannel B for approximately 60 milliseconds to 120 milliseconds (andmost preferably about 100 milliseconds). Thus, there is an overlap ofapproximately 20 milliseconds to 80 milliseconds (and most preferablyabout 20 milliseconds) during which both channel A and channel B areproviding electrical stimulation to the patient. The frequency of theindividual electrical pulses in each phase is approximately 30 Hz to 100Hz (and most preferably about 50 Hz).

Triphasic Sequential Pulse Train Pattern

Referring to FIG. 2C, electrical stimulation device 10 may also be usedto apply a plurality of cycles of a triphasic sequential pulse trainpattern to a patient. In a typical triphasic sequential pulse trainpattern, a first phase of electrical pulses is applied to channel A, asecond phase of electrical pulses is applied to channel B, and a thirdphase of electrical pulses is applied to channel A, wherein there is adelay period between the first and second phases of electrical pulsesand another delay period between the second and third phases ofelectrical pulses.

In the illustrated example, the first phase of electrical pulses isapplied to channel A for approximately 60 milliseconds to 120milliseconds (and most preferably about 100 milliseconds). At theconclusion of the first phase of electrical pulses, there is a delayperiod of approximately 0 milliseconds to 100 milliseconds (and mostpreferably about 80 milliseconds) before the second phase of electricalpulses is applied to channel B. Then, the second phase of electricalpulses is applied to channel B for approximately 60 milliseconds to 120milliseconds (and most preferably about 100 milliseconds). At theconclusion of the second phase of electrical pulses, there is a delayperiod of approximately 0 milliseconds to 100 milliseconds (and mostpreferably about 80 milliseconds) before the third phase of electricalpulses is applied to channel A. Then, the third phase of electricalpulses is applied to channel A for approximately 36 milliseconds to 72milliseconds (and most preferably about 60 milliseconds). The frequencyof the individual electrical pulses in each phase is approximately 30 Hzto 100 Hz (and most preferably about 50 Hz).

Triphasic Overlapping Pulse Train Pattern

Referring to FIG. 2D, electrical stimulation device 10 may also be usedto apply a plurality of cycles of a triphasic overlapping pulse trainpattern to a patient. In a typical triphasic overlapping pulse trainpattern, a first phase of electrical pulses is applied to channel A, asecond phase of electrical pulses is applied to channel B, and a thirdphase of electrical pulses is applied to channel A, wherein there is anoverlap period between the first and second phases of electrical pulsesand another overlap period between the second and third phases ofelectrical pulses.

In the illustrated example, the first phase of electrical pulses isapplied to channel A for approximately 60 milliseconds to 120milliseconds (and most preferably about 100 milliseconds). When thefirst phase of electrical pulses has reached a time period of between 40milliseconds and 100 milliseconds (and most preferably about 80milliseconds), the second phase of electrical pulses is applied tochannel B for approximately 60 milliseconds to 120 milliseconds (andmost preferably about 100 milliseconds). Thus, there is an overlapperiod of approximately 20 milliseconds to 80 milliseconds (and mostpreferably about 20 milliseconds) during which both channel A andchannel B are providing electrical stimulation to the patient. When thesecond phase of electrical pulses has reached a time period of between40 milliseconds and 100 milliseconds (and most preferably about 80milliseconds), the third phase of electrical pulses is applied tochannel A for approximately 36 milliseconds to 72 milliseconds (and mostpreferably about 60 milliseconds) (i.e., the third phase of electricalpulses has a shorter time duration than that of the first phase ofelectrical pulses). Thus, there is an overlap of approximately 20milliseconds to 72 milliseconds (and most preferably about 20milliseconds) during which both channel B and channel A are providingelectrical stimulation to the patient. The frequency of the individualelectrical pulses in each phase is approximately 30 Hz to 100 Hz (andmost preferably about 50 Hz).

Referring now to FIG. 3A-30, electrodes 18 a, 18 b and 20 a, 20 b areeach adapted to be positioned in electrical contact with tissue ofselected regions of a patient. The selected regions are preferably thosethat will assist in programming the central pattern generatorsassociated with the muscles associated with opposing joint movement suchas agonist/antagonist muscle pairs in the neck, trunk, shoulder, arm,wrist, hand, hip, thigh, lower leg, ankle, and foot of the patient thatcontrol intervertebral, elbow, shoulder, wrist, ankle, knee, and hipjoint movement. In the present invention, the muscle contractionsproduced by the pulse train patterns provide afferent inputs or efferentstimulation that assist in retraining the central nervous system andspinal motor loops to promote normal muscle function and decreaseco-contraction. Importantly, it is theorized that biphasic and triphasicpulse train pattern stimulation assists in retraining central patterngenerators when functional pulse train patterns cannot be created eitherbecause of the difficulty in assessing the muscle groups involved or theresearch is too time consuming and costly.

The electrical stimulation methods for reducing joint compression of thepresent invention are well-adapted to be used with other conventionaltherapies for overall joint health, including, but not limited to:implementing a supervised exercise program involving low-impactactivities such as walking, swimming, and cycling; maintaining an idealbody weight; rest periods; applications of heat and cold; applicationsof light or laser; application of pulsed or continuous magnetic fields;application of electrostimulation for pain management; nonsteroidalanti-inflammatory drugs (NSAIDS) or analgesics such as acetaminophen,ibuprofen, naproxen, or aspirin; tramadol; codeine; propoxyphene;glucosamine; chondroitin sulfate; salicylates; Cox-2 NSAIDS; surfaceapplication of capsaicin cream 0.25%; intra-articular injections ofsteroids, corticosteroids, or hyaluronic acid preparations; bracing,splinting, or orthotic treatments; and surgery including jointreplacement and arthroscopic procedures.

While several exemplary embodiments of the present invention arediscussed below, those skilled in the art will readily appreciate thatvarious modifications may be made to these embodiments, and theinvention is not limited to the specific electrode placements and pulsetrain patterns described therein.

First Exemplary Embodiment

In a first exemplary embodiment of the present invention, as generallyillustrated in FIG. 3A, a pair of electrodes is positioned in electricalcontact with the patient's tissue in order to provide electricalstimulation to one or more of the muscles associated with intervertebraland shoulder joint movement. A second pair of electrodes is positionedbilaterally in a similar manner.

More specifically, as shown in FIG. 3A, a two-channel system is used toapply electrical stimulation to agonist/antagonist muscles involved inneck intervertebral and shoulder joint movement. For the first channel,a first electrode 18 a is positioned in electrical contact with tissueto stimulate a motor point of the patient's upper trapezius muscle. Mostpreferably, first electrode 18 a comprises a surface electrode that ispositioned on the patient's skin along the midpoint of the uppertrapezius. A second electrode 18 b is positioned is electrical contactwith tissue to stimulate a motor point of the patient's cervicalparaspinal muscles. Most preferably, second electrode 18 b comprises asurface electrode that is positioned on the patient's skin in theposterior neck region just lateral to one or more of cervical vertebrae,most preferably near the C1, C2, C3, and/or C4 cervical vertebrae. Forthe second channel, a second pair of electrodes 20 a, 20 b is providedbilaterally in a similar position as generally illustrated in FIG. 3A.

In this exemplary embodiment, the pulse train pattern comprises abiphasic overlapping pulse train pattern having the followingparameters:

Pulse duration of individual electrical pulses: 50-70 microseconds

Current amplitude of individual electrical pulses: 20-70 milliamps

Duration of first phase: 100 milliseconds

Duration of overlap: 20 milliseconds

Duration of second phase: 100 milliseconds

Frequency of pulse train pattern: 1.6 Hz

Total treatment time: 20 minutes

Total number of treatments: 18 over six weeks

Frequency of individual electrical pulses (in each phase): 50 Hz

Second Exemplary Embodiment

In a second exemplary embodiment of the present invention, as generallyillustrated in FIG. 3B, two pairs of electrodes are positioned inelectrical contact with the patient's tissue in order to provideelectrical stimulation to one or more of the muscles associated withintervertebral and shoulder joint movement

More specifically, as shown in FIG. 3B, a two-channel system is used toapply electrical stimulation to agonist/antagonist muscles involved inneck intervertebral and shoulder joint movement. For the first channel,a first electrode 18 a is positioned in electrical contact with tissueto stimulate a motor point of the patient's lower cervical and upperthoracic paraspinal muscles. Most preferably, first electrode 18 acomprises a surface electrode that is positioned on the patient's skinalong the midpoint of the upper trapezius just lateral to the spinalcord, most preferably near the C6, C7, T1, T2, T3, and/or T4 cervicaland thoracic vertebrae. A second electrode 18 b is positioned inelectrical contact with tissue to stimulate a motor point of thepatient's cervical paraspinal muscles. Most preferably, second electrode18 b comprises a surface electrode that is positioned on the patient'sskin in the posterior neck region just lateral to one or more cervicalvertebrae, most preferably near the C1, C2, C3, and/or C4 cervicalvertebrae. For the second channel, a second pair of electrodes 20 a, 20b is provided bilaterally in a similar position as generally illustratedin FIG. 3B.

In this exemplary embodiment, the pulse train pattern comprises abiphasic overlapping pulse train pattern having the followingparameters:

Pulse duration of individual electrical pulses: 50-70 microseconds

Current amplitude of individual electrical pulses: 20-70 milliamps

Duration of first phase: 100 milliseconds

Duration of overlap: 20 milliseconds

Duration of second phase: 100 milliseconds

Frequency of pulse train pattern: 1.6 Hz

Total treatment time: 20 minutes

Total number of treatments: 18 (over six weeks)

Frequency of individual electrical pulses (in each phase): 50 Hz

Third Exemplary Embodiment

In a third exemplary embodiment of the present invention, as generallyillustrated in FIG. 3C, two pairs of electrodes are positioned inelectrical contact with the patient's tissue in order to provideelectrical stimulation to one or more of the muscles associated withintervertebral joint movement.

More specifically, as shown in FIG. 3C, a two channel system is used toapply electrical stimulation to agonist/antagonist muscles involved inupper and mid-back intervertebral joint movement including the erectorspinae and trapezius muscles. For the first channel, a first electrode18 a is positioned in electrical contact with tissue to stimulate amotor point of the patient's thoracic paraspinal muscles. Mostpreferably, first electrode 18 a comprises a surface electrode that ispositioned on the patient's skin just lateral to one or more thoracicvertebrae, most preferably near the T3, T4, T5, T6, T7, T8, and/or T9thoracic vertebrae. A second electrode 18 b is positioned in electricalcontact with tissue to stimulate a motor point of the patient's upperthoracic paraspinal muscles. Most preferably, second electrode 18 acomprises a surface electrode that is positioned on the patient's skinalong the midpoint of the upper trapezius just lateral to the spinalcord, most preferably near the C7, T1, T2, T3, and/or T4 cervical andthoracic vertebrae. For the second channel, a second pair of electrodes20 a, 20 b is provided bilaterally in a similar position as generallyillustrated in FIG. 3C.

In this exemplary embodiment, the pulse train pattern comprises abiphasic overlapping pulse train pattern having the followingparameters:

Pulse duration of individual electrical pulses: 50-70 microseconds

Current amplitude of individual electrical pulses: 20-70 milliamps

Duration of first phase: 100 milliseconds

Duration of overlap: 20 milliseconds

Duration of second phase: 100 milliseconds

Frequency of pulse train pattern: 1.6 Hz

Total treatment time: 20 minutes

Total number of treatments: 36

Frequency of individual electrical pulses (in each phase): 50 Hz

Fourth Exemplary Embodiment

In a fourth exemplary embodiment of the present invention, as generallyillustrated in FIG. 3D, a pair of electrodes is positioned in electricalcontact with the patient's tissue in order to provide electricalstimulation to one or more of the muscles associated with intervertebraljoint movement. A second pair of electrodes is positioned bilaterally ina similar manner.

More specifically, as shown in FIG. 3D, a two-channel system is used toapply electrical stimulation to agonist/antagonist muscles involved inlumbar intervertebral joint movement. For the first channel, a firstelectrode 18 a is positioned in electrical contact with tissue tostimulate a motor point of the patient's lower back muscles. Mostpreferably, first electrode 18 a comprises a surface electrode that ispositioned posteriorly on the patient's skin in the lower back regionover the lower paraspinal muscles just lateral to one or more of thelower thoracic and/or lumbar vertebrae, most preferably near the L1, L2,L3, L4, and/or L5 lumbar vertebrae. A second electrode 18 b ispositioned in electrical contact with tissue to stimulate a motor pointof the patient's abdominal muscles. Most preferably, second electrode 18b comprises a surface electrode that is positioned anteriorly on thepatient's skin at about the level of the umbilicus, about half-waybetween the anterior superior iliac spine (“ASIS”) and the anteriormidline over the combined abdominal muscle. For the second channel, asecond pair of electrodes 20 a, 20 b is provided bilaterally in asimilar position as generally illustrated in FIG. 3D.

In this exemplary embodiment, the pulse train pattern comprises atriphasic overlapping pulse train pattern having the followingparameters:

Pulse duration of individual electrical pulses: 50-70 microseconds

Current amplitude of individual electrical pulses: 20-90 milliamps

Duration of first phase: 200 milliseconds

Duration of overlap: 40 milliseconds

Duration of second phase: 200 milliseconds

Duration of overlap: 40 milliseconds

Duration of third phase: 120 milliseconds

Frequency of pulse train pattern: 0.67 Hz

Frequency of individual electrical pulses (in each phase): 50 hertz

Total treatment time: 20 minutes

Total number of treatments: 18 over six weeks

Fifth Exemplary Embodiment

In a fifth exemplary embodiment of the present invention, as generallyillustrated in FIG. 3E, four pairs of electrodes are positioned inelectrical contact with the patient's tissue in order to provideelectrical stimulation to one or more of the muscles associated withintervertebral joint movement. Two channels may be used with abifurcating cable as illustrated in FIG. 3E.

More specifically, as shown in FIG. 3E, a two-channel system is used toapply electrical stimulation to agonist/antagonist muscles involved intrunk intervertebral joint movement. For the first channel, a firstelectrode 18 a is positioned in electrical contact with tissue tostimulate a motor point of the patient's upper lumbar and upperabdominal muscles. Most preferably, first electrode 18 a comprises asurface electrode that is positioned posteriorly on the patient's skinin the lower back region over the multifidus muscle, just lateral to oneor more of the lower thoracic and/or lumbar vertebrae, most preferablynear the L1, L2, L3, L4, and/or L5 lumbar vertebrae. A second electrode18 b of the first channel is also placed posteriorly on the patient'sskin in the lower back region over the multifidus muscle, just lateralto one or more of the lower thoracic and/or lumbar vertebrae, mostpreferably near the T9, T10, T11, T12, L1, L2, and/or L3 lumbarvertebrae. A third electrode 18 c and a fourth electrode 18 d are placedover the same side of the abdominal muscles at the same vertebral levelto stimulate the patient's lower abdominal muscles. Another set of fourelectrodes 20 a, 20 b, 20 c, and 20 d is provided bilaterally in asimilar position as generally illustrated in FIG. 3E.

In this exemplary embodiment, the pulse train pattern comprises atriphasic overlapping pulse train pattern having the followingparameters:

Pulse duration of individual electrical pulses: 50-70 microseconds

Current amplitude of individual electrical pulses: 20-70 milliamps

Duration of first phase: 200 milliseconds

Duration of overlap: 40 milliseconds

Duration of second phase: 200 milliseconds

Duration of overlap: 40 milliseconds

Duration of third phase: 120 milliseconds

Frequency of pulse train pattern: 0.67 Hz

Frequency of individual electrical pulses (in each phase): 50 Hz

Total treatment time: 20 minutes

Total number of treatments: 18 over six weeks

Sixth Exemplary Embodiment

In a sixth exemplary embodiment of the present invention, also generallyillustrated in FIG. 3F, two pairs of electrodes are positioned inelectrical contact with the patient's tissue in order to provideelectrical stimulation to one or more of the muscles associated withelbow flexion/extension.

More specifically, as shown in FIG. 3F, a two-channel system is used toapply electrical stimulation to muscles of the upper arm. For the firstchannel, a first electrode 18 a and a second electrode 18 b arepositioned in electrical contact with tissue to stimulate motor pointsof the patient's biceps brachii muscles (flex the forearm at the elbow).Most preferably, first electrode 18 a comprises a surface electrode thatis positioned on the patient's skin on the anterior side of the upperarm just above the insertion of the biceps brachii muscles. Mostpreferably, second electrode 18 b comprises a surface electrode that ispositioned on the patient's skin on the anterior side of the upper armjust below the origin of the biceps brachii muscles.

For the second channel, a first electrode 20 a and a second electrode 20b are positioned in electrical contact with tissue to stimulate motorpoints of the patient's triceps brachii muscles (extend the forearm atthe elbow). Most preferably, first electrode 20 a comprises a surfaceelectrode that is positioned on the patient's skin on the posterior sideof the upper arm above the insertion of the triceps brachii muscles.Most preferably, second electrode 20 b comprises a surface electrodethat is positioned on the patient's skin on the posterior side of theupper arm below the origin of the triceps brachii muscles.

During treatment, the first and second channels are positioned on theright or left arm, and a patterned pulse train is applied to the upperarm as discussed more fully below. It will be appreciated that themuscles involved in elbow flexion/extension may be bilaterallystimulated when the electrical stimulation device contains at least fourchannels. Alternatively, two electrical stimulation devices can be usedfor bilateral stimulation: one to stimulate the right upper arm, and oneto stimulate the left upper arm.

In this exemplary embodiment, the pulse train pattern comprises atriphasic overlapping pulse train pattern having the followingparameters:

Pulse duration of individual electrical pulses: 50-70 microseconds

Current amplitude of individual electrical pulses: 30-70 milliamps

Duration of first phase: 100 milliseconds

Duration of overlap between first and second phases: 20 milliseconds

Duration of second phase: 100 milliseconds

Duration of overlap between second and third phases: 20 milliseconds

Duration of third phase: 60 milliseconds

Frequency of pulse train pattern: 0.67 Hz

Total treatment time: 20 minutes

Total number of treatments: 18 during six weeks

Frequency of individual electrical pulses (in each phase): 50 Hz

Seventh Exemplary Embodiment

In a seventh exemplary embodiment of the present invention, as generallyillustrated in FIG. 3G, two pairs of electrodes are positioned inelectrical contact with the patient's tissue in order to provideelectrical stimulation to one or more of the muscles involved in theinternal and external rotation of the shoulder.

More specifically, as shown in FIG. 3G, a two channel system is used toapply electrical stimulation to agonist/antagonist muscles involved inshoulder movement. For the first channel, a first pair of electrodes 18a, 18 b is positioned to provide simulation to muscles involved in theinternal rotation of the shoulder. A first electrode 18 a is positionedin electrical contact with tissue to stimulate a motor point of thepatient's biceps brachii muscle. Most preferably, first electrode 18 acomprises a surface electrode that is positioned on the patient's skinnear the midpoint of the biceps brachii muscle. A second electrode 18 bis positioned in electrical contact with tissue to stimulate a motorpoint of the patient's pectoralis major and anterior deltoid muscle.Most preferably, second electrode 18 b comprises a surface electrodethat is positioned anteriorly on the patient's skin just above theaxilla.

For the second channel, a second pair of electrodes 20 a, 20 b isprovided to stimulate the muscles involved in the external rotation ofthe shoulder. A first electrode 20 a is positioned in electrical contactwith tissue to stimulate a motor point of the patient's triceps brachiimuscle. Most preferably, first electrode 20 a comprises a surfaceelectrode that is positioned near the midpoint of the triceps brachii. Asecond electrode 20 b is positioned in electrical contact with tissue tostimulate a motor point of the patient's infraspinatus teres minor andthe posterior deltoid muscle. Most preferably, second electrode 20 bcomprises a surface electrode that is positioned posteriorly on thepatient's skin just above the underarm.

During treatment, the first and second channels are positioned on theright or left arm, and a patterned pulse train is applied as discussedmore fully below. It will be appreciated that the muscles involved inshoulder rotation may be bilaterally stimulated when the electricalstimulation device contains at least four channels. Alternatively, twoelectrical stimulation devices can be used for bilateral stimulation:one to simulate the right shoulder, and one to stimulate the leftshoulder.

In this exemplary embodiment, the pulse train pattern comprises atriphasic overlapping pulse train pattern having the followingparameters:

Pulse duration of individual electrical pulses: 50-70 microseconds

Current amplitude of individual electrical pulses: 30-70 milliamps

Duration of first phase: 100 milliseconds

Duration of overlap: 20 milliseconds

Duration of second phase: 100 milliseconds

Duration of overlap: 20 milliseconds

Duration of third phase: 60 milliseconds

Frequency of pulse train pattern: 0.67 Hz

Total treatment time: 20 minutes

Total number of treatments: 18 over six weeks

Frequency of individual electrical pulses (in each phase): 50 Hz

Eighth Exemplary Embodiment

In an eighth exemplary embodiment of the present invention, as generallyillustrated in FIG. 3H, two pairs of electrodes are positioned inelectrical contact with the patient's tissue in order to provideelectrical stimulation to one or more of the muscles involved inshoulder and elbow flexion/extension.

More specifically, as shown in FIG. 3H, a two-channel system is used toapply electrical stimulation to agonist/antagonist muscles involved inshoulder and elbow extension/flexion. For the first channel, a firstelectrode 18 a is positioned in electrical contact with tissue tostimulate a motor point of the patient's biceps brachii muscle. Mostpreferably, first electrode 18 a comprises a surface electrode that ispositioned on the patient's skin near the midpoint of the biceps brachiimuscle. A second electrode 18 b is positioned in electrical contact withtissue to stimulate a motor point of the patient's anterior deltoidmuscle. Most preferably, second electrode 18 b comprises a surfaceelectrode that is positioned anteriorly on the patient's skin just abovethe axilla.

For the second channel, a first electrode 20 a is positioned inelectrical contact with tissue to stimulate a motor point of thepatient's triceps brachii muscle. Most preferably, first electrode 20 acomprises a surface electrode that is positioned near the distal end ofthe triceps brachii. A second electrode 20 b is positioned in electricalcontact with tissue to stimulate a motor point of the patient'sposterior deltoid muscle. Most preferably, second electrode 20 bcomprises a surface electrode that is positioned posteriorly on thepatient's skin just above the axilla.

During treatment, the first and second channels are positioned on theright or left arm, and a patterned pulse train is applied as discussedmore fully below. It will be appreciated that the muscles involved inshoulder rotation may be bilaterally stimulated when the electricalstimulation device contains at least four channels. Alternatively, twoelectrical stimulation devices can be used for bilateral stimulation:one to simulate the right shoulder, and one to stimulate the leftshoulder.

In this exemplary embodiment, the pulse train pattern comprises atriphasic overlapping pulse train pattern having the followingparameters:

Pulse duration of individual electrical pulses: 50-70 microseconds

Current amplitude of individual electrical pulses: 30-70 milliamps

Duration of first phase: 100 milliseconds

Duration of overlap: 20 milliseconds

Duration of second phase: 100 milliseconds

Duration of overlap: 20 milliseconds

Duration of third phase: 60 milliseconds

Frequency of pulse train pattern: 0.67 Hz

Total treatment time: 20 minutes

Total number of treatments: 18 (over six weeks)

Frequency of individual electrical pulses (in each phase): 50 Hz

Ninth Exemplary Embodiment

In a ninth exemplary embodiment of the present invention, also generallyillustrated in FIG. 3I, two pairs of electrodes are positioned inelectrical contact with the patient's tissue in order to provideelectrical stimulation to one or more of the muscles associated withwrist flexion/extension, wrist pronation/supination, and/or fingerflexion/extension. The treated muscles include the flexor digitorumsuperficialis, flexor carpi radialis, flexor carpi ulnaris, extensordigitorum. extensor digiti minimi muscle, extensor carpi ulnaris,extensor carpi radialis longus, and/or extensor carpi radialis brevis.

More specifically, as shown in FIG. 3I, a two-channel system is used toapply electrical stimulation to muscles of the wrist and fingers. Forthe first channel, a first electrode 18 a is positioned in electricalcontact with tissue of the patient's proximal palmar surface tostimulate motor points of the patient's intrinsic hand muscles. Mostpreferably, first electrode 18 a comprises a surface electrode that ispositioned on the patient's skin across the thenar and the hypothenareminence on the palmar/anterior side of the forearm arm at the base ofthe wrist just below the wrist crease. A second electrode 18 b ispositioned in electrical contact with tissue to stimulate motor pointsof the patient's volar-surface, proximal forearm muscles. Mostpreferably, second electrode 18 b comprises a surface electrode that ispositioned on the patient's skin on the palmar/anterior side of thelower arm just below the elbow joint.

For the second channel, a first electrode 20 a is positioned inelectrical contact with tissue to stimulate a motor point of thepatient's extensor digitorum muscle (extends medial four digits atmetacarpophalangeal joints, and extends the hand at the wrist) andpollicis muscles. Most preferably, first electrode 20 a comprises asurface electrode that is positioned on the patient's skin on thedorsal/posterior side of the lower arm on the distal one-third betweenthe wrist crease and the elbow joint. A second electrode 20 b ispositioned in electrical contact with a tissue to stimulate motor pointsof the patient's proximal extensor muscles of the forearm. Mostpreferably, second electrode 20 b comprises a surface electrode that ispositioned on the patient's skin on the dorsal/posterior side of thelower arm just below the elbow joint.

During treatment, the first and second channels are positioned on theright or left arm, and a patterned pulse train is applied to the arm andwrist as discussed more fully below. It will be appreciated that themuscles involved in wrist and finger extension/flexion may bebilaterally stimulated when the electrical stimulation device containsat least four channels.

Alternatively, two electrical stimulation devices can be used forbilateral stimulation: one to stimulate the right wrist and fingers, andone to stimulate the left wrist and fingers.

In this exemplary embodiment, the pulse train pattern comprises atriphasic overlapping pulse train pattern having the followingparameters:

Pulse duration of individual electrical pulses: 50-70 microseconds

Current amplitude of individual electrical pulses: 30-70 milliamps

Duration of first phase: 100 milliseconds

Duration of overlap between first and second phases: 20 milliseconds

Duration of second phase: 100 milliseconds

Duration of overlap between second and third phases: 20 milliseconds

Duration of third phase: 60 milliseconds

Frequency of pulse train pattern: 0.67 Hz

Total treatment time: 20 minutes

Total number of treatments: 18 during six weeks

Frequency of individual electrical pulses (in each phase): 50 Hz

Tenth Exemplary Embodiment

In a tenth exemplary embodiment of the present invention, also generallyillustrated in FIG. 3J, two pairs of electrodes are positioned inelectrical contact with the patient's tissue in order to provideelectrical stimulation to one or more of the muscles involved in wristand elbow movement.

More specifically, as shown in FIG. 3J, a two-channel system is used toapply electrical stimulation to agonist/antagonist muscles involved inwrist and elbow movement. For the first channel, a first pair ofelectrodes 18 a, 18 b provide stimulation to the anterior portion of thearm. A first electrode 18 a is positioned in electrical contact withtissue of the proximal palmar surface to stimulate a motor point of thepatient's intrinsic hand muscles. Most preferably, first electrode 18 acomprises a surface electrode that is positioned on the patient's skinacross the thenar and hypothenar eminence of the palmar/anterior side ofthe forearm at the base of the wrist just below the wrist crease. Asecond electrode 18 b is positioned in electrical contact with tissue tostimulate a motor point of the patient's biceps brachii muscles, themedian nerve, and the ulnar nerve. Most preferably, second electrode 18b comprises a surface electrode that is positioned on the patient's skinanterior and medially (to capture the median and ulnar nerve bundle)near the midpoint of the biceps brachii muscles.

For the second channel, a second pair of electrodes 20 a, 20 b isprovided to stimulate the posterior muscles of the arm. A firstelectrode 20 a is positioned in electrical contact with tissue tostimulate a motor point of the patient's proximal extensor muscles ofthe forearm. Most preferably, first electrode 20 a comprises a surfaceelectrode that is positioned on the patient's skin on thedorsal/posterior side of the lower arm just below the elbow joint. Asecond electrode 20 b is positioned in electrical contact with tissue tostimulate a motor point of the patient's triceps brachii muscles. Mostpreferably, second electrode 20 b comprises a surface electrode that ispositioned on the patient's skin on the posterior side of the arm nearthe midpoint of the triceps brachii muscles.

During treatment, the first and second channels are positioned on theright or left arm, and a patterned pulse train is applied to the arm andwrist as discussed more fully below. It will be appreciated that themuscles involved in arm movement may be bilaterally stimulated when theelectrical stimulation device contains at least four channels.Alternatively, two electrical stimulation devices can be used forbilateral stimulation: one to stimulate the right arm, and one tostimulate the left arm.

In this exemplary embodiment, the pulse train pattern comprises atriphasic overlapping pulse train pattern having the followingparameters:

Pulse duration of individual electrical pulses: 50-70 microseconds

Current amplitude of individual electrical pulses: 30-70 milliamps

Duration of first phase: 100 milliseconds

Duration of overlap between first and second phases: 20 milliseconds

Duration of second phase: 100 milliseconds

Duration of overlap between second and third phases: 20 milliseconds

Duration of third phase: 60 milliseconds

Frequency of pulse train pattern: 0.67 Hz

Total treatment time: 20 minutes

Total number of treatments: 18 during six weeks

Frequency of individual electrical pulses (in each phase): 50 Hz

Eleventh Exemplary Embodiment

In an eleventh exemplary embodiment of the present invention, asgenerally illustrated in FIG. 3K, two pairs of electrodes are positionedin electrical contact with the patient's tissue in order to provideelectrical stimulation to one or more of the muscles associated with toeand ankle dorsiflexion (or extension) and flexion (or plantar flexion).

More specifically, as shown in FIG. 3K, a two-channel system is used toapply electrical stimulation to agonist/antagonist muscles involved intoe and ankle extension/flexion. For the first channel, a firstelectrode 18 a is positioned in electrical contact with tissue tostimulate a motor point of the patient's extensor digitorum brevismuscle (extends the joints of the proximal phalanges of toes 1-4). Mostpreferably, first electrode 18 a comprises a surface electrode that ispositioned on the patient's skin on the dorsum of the foot over thefirst four metatarsal bones. A second electrode 18 b is positioned inelectrical contact with tissue to stimulate a motor point of thepatient's tibialis anterior (extends foot at the ankle), extensordigitorum longus (extends toes 2-5 and the foot at the ankle), and/orextensor hallucis longus (extends toe 1 and the foot at the ankle)muscles. Most preferably, second electrode 18 b comprises a surfaceelectrode that is positioned on the patient's skin at the anteriorlateral mid-shaft of the leg over the mid-tibialis anterior and theapproximate mid-belly of the extensor digitorum longus and extensorhallucis longus muscles.

For the second channel, a first electrode 20 a is positioned inelectrical contact with tissue to stimulate motor points of thepatient's intrinsic foot muscles. Most preferably, first electrode 20 acomprises a surface electrode that is positioned on the patient's skinon the sole of the foot at the anterior one-third junction to includethe abductor hallucis. A second electrode 20 b is positioned inelectrical contact with tissue to stimulate motor points of thepatient's tibialis posterior (flexes the foot at the ankle) and flexorhallucis muscles. Most preferably, second electrode 20 b comprises asurface electrode that is positioned on the patient's skin on theposterior distal one-third of the lower leg.

During treatment, the first and second channels are positioned on theright or left leg, and a patterned pulse train is applied to the leg asdiscussed more fully below. It will be appreciated that the musclesinvolved in toe and ankle extension/flexion may be bilaterallystimulated when the electrical stimulation device contains at least fourchannels. Alternatively, two electrical stimulation devices can be usedfor bilateral stimulation: one to stimulate the right leg, and one tostimulate the left leg.

In this exemplary embodiment, the pulse train pattern comprises atriphasic overlapping pulse train pattern having the followingparameters:

Pulse duration of individual electrical pulses: 50-70 microseconds

Current amplitude of individual electrical pulses: 30-70 milliamps

Duration of first phase: 200 milliseconds

Duration of overlap between first and second phase: 40 milliseconds

Duration of second phase: 200 milliseconds

Duration of overlap between second and third phase: 40 milliseconds

Duration of third phase: 120 milliseconds

Frequency of pulse train pattern: 0.67 Hz

Total treatment time: 20 minutes

Total number of treatments: 18 during six weeks

Frequency of individual electrical pulses (in each phase): 50 Hz

Twelfth Exemplary Embodiment

In a twelfth exemplary embodiment of the present invention, generallyillustrated in FIG. 3L, two pairs of electrodes are positioned inelectrical contact with the patient's tissue in order to provideelectrical stimulation to one or more of the muscles associated withankle dorsiflexion and plantar flexion and ankle eversion/inversion.

More specifically, as shown in FIG. 3L, a two-channel system is used toapply electrical stimulation to muscles involved in ankle dorsiflexionand plantar flexion and/or ankle inversion/eversion. For the firstchannel (panel 1 of FIG. 3L), a first electrode 18 a is positioned inelectrical contact with tissue to stimulate a motor point of thepatient's lower portion of the tibialis anterior muscle. Mostpreferably, first electrode 18 a comprises a surface electrode that ispositioned on the patient's skin over the mid-belly of the tibialisanterior muscle. A second electrode 18 b is positioned in electricalcontact with tissue to stimulate a motor point of the patient's proximaltibialis anterior muscle. Most preferably, second electrode 18 bcomprises a surface electrode that is positioned on the patient's skininferior to the fibular head.

Alternatively, for the first channel (panel 2 of FIG. 3L), a firstelectrode 18 a is positioned in electrical contact with tissue tostimulate motor points of the patient's anterior and lateral muscles ofthe leg. Most preferably, first electrode 18 a comprises a surfaceelectrode that is positioned on the patient's skin at the mid-belly ofthe tibialis anterior as well as the peroneus muscles. A secondelectrode 18 b is positioned in electrical contact with tissue tostimulate a motor point of the patient's proximal tibialis anteriormuscle. Most preferably, second electrode 18 b comprises a surfaceelectrode that is positioned on the patient's skin inferior to thefibular head.

For the second channel (panel 3 of FIG. 3L), a first electrode 20 a anda second electrode 20 b are positioned in electrical contact with tissueto stimulate motor points of the patient's triceps surae (comprised ofthe gastrocnemius medial head (which plantar flexes the foot at theankle), the gastrocnemius lateral head (which plantar flexes foot at theankle), and/or the soleus muscle (which plantar flexes the foot at theankle)). Most preferably, first electrode 20 a comprises a surfaceelectrode that is positioned on the patient's skin directly over thejunction of the gastrocnemius and soleus muscles. Most preferably,second electrode 20 b comprises a surface electrode that is positionedon the patient's skin posteriorly just inferior to the popliteal fossaover the tibial nerve and the two heads of the gastrocnemius muscle.

During treatment, the first and second channels are positioned on theright or left leg, and a patterned pulse train is applied to the leg asdiscussed more fully below. It will be appreciated that the musclesinvolved in ankle dorsiflexion and plantar flexion and/or ankleinversion/eversion may be bilaterally stimulated when the electricalstimulation device contains at least four channels. Alternatively, twoelectrical stimulation devices can be used for bilateral stimulation:one to stimulate the right leg, and one to stimulate the left leg.

In this exemplary embodiment, the pulse train pattern comprises atriphasic overlapping pulse train pattern having the followingparameters:

Pulse duration of individual electrical pulses: 50-70 microseconds

Current amplitude of individual electrical pulses: 30-70 milliamps

Duration of first phase: 200 milliseconds

Duration of overlap between first and second phase: 40 milliseconds

Duration of second phase: 200 milliseconds

Duration of overlap between second and third phase: 40 milliseconds

Duration of third phase: 120 milliseconds

Frequency of pulse train pattern: 0.67 Hz

Total treatment time: 20 minutes

Total number of treatments: 18 during six weeks

Frequency of individual electrical pulses (in each phase): 50 Hz

Thirteenth Exemplary Embodiment

In a thirteenth exemplary embodiment of the present invention, alsogenerally illustrated in FIG. 3M, two pairs of electrodes are positionedin electrical contact with the patient's tissue in order to provideelectrical stimulation to one or more of the muscles associated withmovement in the lower extremities.

More specifically, as generally shown in FIG. 3M, a two-channel systemis used to apply electrical stimulation to muscles involved in legmovement. For the first channel, a first electrode 18 a is positioned inelectrical contact with tissue to stimulate a motor point of thepatient's proximal tibialis anterior muscle. Most preferably, firstelectrode 18 a comprises a surface electrode that is positioned on thepatient's skin on the anterior side of the leg and inferior to thefibular head. A second electrode 18 b is positioned in electricalcontact with tissue to stimulate a motor point near the midpoint of apatient's quadriceps muscles. Most preferably, second electrode 18 bcomprises a surface electrode that is positioned on the patient's skinon the anterior side of the leg just above the knee.

For the second channel, a first electrode 20 a is positioned inelectrical contact with tissue to stimulate a motor point of thepatient's triceps surae muscles. Most preferably, first electrode 20 acomprises a surface electrode that is positioned on the patient's skinon the posterior side of the lower leg near the midpoint of thegastrocnemius muscle. The second electrode 20 b is positioned inelectrical contact with a tissue to stimulate a motor point of thepatient's mid-hamstrings. Most preferably, second electrode 20 bcomprises a surface electrode that is positioned on the patient's skinon the distal one third of the posterior side of the leg.

During treatment, the first and second channels are positioned on theright or left leg, and a patterned pulse train is applied to the leg asdiscussed more fully below. It will be appreciated that the musclesinvolved in leg movement may be bilaterally stimulated when theelectrical stimulation device contains at least four channels.Alternatively, two electrical stimulation devices can be used forbilateral stimulation: one to stimulate the right leg, and one tostimulate the left leg.

In this exemplary embodiment, the pulse train pattern comprises atriphasic overlapping pulse train pattern having the followingparameters:

Pulse duration of individual electrical pulses: 50-100 microseconds

Current amplitude of individual electrical pulses: 30-90 milliamps

Duration of first phase: 200 milliseconds

Duration of overlap between first and second phases: 40 milliseconds

Duration of second phase: 200 milliseconds

Duration of overlap between second and third phases: 40 milliseconds

Duration of third phase: 120 milliseconds

Frequency of pulse train pattern: 0.67 Hz

Total treatment time: 20 minutes

Total number of treatments: 18 during six weeks

Frequency of individual electrical pulses (in each phase): 50 Hz

Fourteenth Exemplary Embodiment

In a fourteenth exemplary embodiment of the present invention, generallyillustrated in FIG. 3N, a pair of electrodes is positioned in electricalcontact with the patient's tissue in order to provide electricalstimulation to one or more of the muscles associated with hip abductionand knee extension as well as hip adduction and knee flexion(stabilization).

More specifically, as generally shown in FIG. 3N, a two-channel systemis used to apply electrical stimulation to muscles involved in hipabduction/adduction and knee extension/flexion. For the first channel, afirst electrode 18 a is positioned in electrical contact with thequadricep muscles, and in particular to stimulate the motor point of thevastus medialis, which functions as an extensor of the knee. A secondelectrode 18 b is positioned in electrical contact with tissue tostimulate the gluteus medius, gluteus minimus, and tensor faciae latae.Preferably, the second electrode 18 b is positioned about midway betweenthe iliac crest and the greater trochanter. For the second channel, afirst electrode 20 a is positioned in electrical contact with tissue tostimulate the patient's hamstring muscles (biceps femoris,semitendinosus, and/or semimembraneous muscles). A second electrode 20 bis positioned in electrical contact with tissue to stimulate theadductor magnus, adductor longus, adductor brevis, and medial hamstringmuscles.

The far right panel of FIG. 3N shows the hip extensor alternativeplacement: In the second channel, a first electrode 20 a is positionedin electrical contact with tissue to stimulate the adductor magnus,adductor longus, adductor brevis and medial hamstring muscles. A secondelectrode 20 b is positioned in electrical contact with tissue tostimulate the mid-belly of the gluteus maximus.

During treatment, the first and second channels are positioned on theright or left leg, and a patterned pulse train is applied to the leg asdiscussed more fully below. It will be appreciated that the musclesinvolved in hip abduction/adduction and knee extension/flexion may bebilaterally stimulated when the electrical stimulation device containsat least four channels. Alternatively, two electrical stimulationdevices can be used for bilateral stimulation: one to simulate the rightleg, and one to stimulate the left leg.

In this exemplary embodiment, the pulse train pattern comprises atriphasic overlapping pulse train pattern having the followingparameters:

Pulse duration of individual electrical pulses: 50-200 microseconds

Current amplitude of individual electrical pulses: 30-140 milliamps

Duration of first phase: 200 milliseconds

Duration of overlap between first and second phase: 40 milliseconds

Duration of second phase: 200 milliseconds

Duration of overlap between second and third phase: 40 milliseconds

Duration of third phase: 120 milliseconds

Frequency of pulse train pattern: 0.67 Hz

Total treatment time: 20 minutes

Total number of treatments: 18 during six weeks

Frequency of individual electrical pulses (in each phase): 50 Hz

Fifteenth Exemplary Embodiment

In an eighth exemplary embodiment of the present invention, alsogenerally illustrated in FIG. 3O, two pairs of electrodes are positionedin electrical contact with the patient's tissue in order to provideelectrical stimulation to one or more of the muscles associated withknee extension/flexion as a treatment for joint compression in the lowerextremities.

More specifically, as generally shown in FIG. 3O, a two-channel systemis used to apply electrical stimulation to muscles involved in kneeextension/flexion. For the first channel, a first electrode 18 a ispositioned in electrical contact with tissue to stimulate a motor pointof the patient's rectus femoris (extends leg at the knee) and vastuslateralis (extends leg at the knee) muscles. Most preferably, firstelectrode 18 a comprises a surface electrode that is positioned on thepatient's skin on the proximal one third of the anterior side of theupper leg. A second electrode 18 b is positioned in electrical contactwith tissue to stimulate the motor point of the patient's vastusmedialis muscle (extends the leg at the knee). Most preferably, secondelectrode 18 b comprises a surface electrode that is positioned on thepatient's skin on the anterior medial side of the upper leg just abovethe knee.

For the second channel, a first electrode 20 a is positioned inelectrical contact with tissue to stimulate a motor point of thepatient's distal portion of the biceps femoris muscle (flexes the leg atthe knee), semimembranosus muscle (flexes the leg at the knee), and/orsemitendinosus muscle (flexes the leg at the knee). Most preferably,first electrode 20 a comprises a surface electrode that is positioned onthe patient's skin on the posterior side of the upper leg just above theknee. A second electrode 20 b is positioned in electrical contact with atissue to stimulate a motor point of the patient's proximal portion ofthe biceps femoris, semimembranosus, and/or semitendinosus muscles. Mostpreferably, second electrode 20 b comprises a surface electrode that ispositioned on the patient's skin on the proximal one third of theposterior side of the upper leg.

During treatment, the first and second channels are positioned on theright or left leg, and a patterned pulse train is applied to the leg asdiscussed more fully below. It will be appreciated that the musclesinvolved in knee flexion/extension may be bilaterally stimulated whenthe electrical stimulation device contains at least four channels.Alternatively, two electrical stimulation devices can be used forbilateral stimulation: one to stimulate the right leg, and one tostimulate the left leg.

In this exemplary embodiment, the pulse train pattern comprises atriphasic overlapping pulse train pattern having the followingparameters:

Pulse duration of individual electrical pulses: 50-200 microseconds

Current amplitude of individual electrical pulses: 30-140 milliamps

Duration of first phase: 200 milliseconds

Duration of overlap between first and second phases: 40 milliseconds

Duration of second phase: 200 milliseconds

Duration of overlap between second and third phases: 40 milliseconds

Duration of third phase: 120 milliseconds

Frequency of pulse train pattern: 0.67 Hz

Total treatment time: 20 minutes

Total number of treatments: 18 during six weeks

Frequency of individual electrical pulses (in each phase): 50 Hz

Example 1 Measuring Muscle Hardness

In this example, muscle hardness was correlated to I-EMG ratios. Morespecifically, fourteen healthy female subject were seated in a fixedposition, and postured with the hip joint at a 60 degree angle, with thebody trunk fixed by a belt. The arms were positioned on the sides of thebody and the hands were positioned on the anterior edge of the chair.Tissue compliance (hardness) was measured 22 cm above the right superiorborder patella at the thigh center line using the ACP Tissue ComplianceMeter. EMG pads were positioned on the right quadricepts femoris muscle.One electrode was positioned 9 cm above the right superior borderpaella, and the other electrode was positioned a center of the thighline between 9 to 17 cm above the right superior patella with the groundin the center.

Six tests were performed on each subject. For the first test, thesubject's knee was flexed at a 60 degree angle with no load. The EMG wasmeasured for 10 seconds, and the tissue compliance (hardness) wasmeasured three times during the ten-second interval.

For the remaining five tests, the subject's knee was flexed at a 60degree angle and a motorized dynamometer was used to apply a load of 10,20, 30, 40, and 60 pounds. The EMG was measured when the applied loadwas reached during each contraction for a period of 10 seconds while thecontraction was maintained The tissue compliance (hardness) was measuredthree times during the ten-second interval while the EMG was beingmeasured.

As shown in FIG. 4, the tissue compliance (hardness, lbs) was plotted asa function of I-EMG. (mV) Increasing I-EMG resulted in increasing tissuehardness (tissue compliance). Thus, this figure shows that musclecontraction can be indirectly measured by the I-EMG of the subject.

As shown in FIG. 5, the tissue compliance (hardness, lbs) was plotted asa function of FFT (median Hz). Increasing tissue compliance resulted inincreasing FFT. Thus, this figure shows that muscle contraction can beindirectly measured by the shift in the median FFT frequency of thesubject.

As shown in FIG. 6, FFT (median Hz) was plotted as a function of I-EMG(mV)

The FFT increased with increasing I-EMG. This indicates that FTT andI-EMG are related to each other and the muscle hardness (tissuecompliance).

Example 2 Joint Study

In this example, neuromuscular electrical stimulation having a triphasicpulse train pattern was applied to the knee joint over a 24-week periodto five patients. All of the paitents exhibited evidence ofosteoarthritis (radiographic and/or by patient symptoms report) in morethan one joint; however, osteoarthritis of one knee has been thepatient's primary complaint and the focus of treatment. The patientsalso exhibited a Kellgren and Lawrence osteoarthritis classificationgrade 1, 2 or 3 (i.e., indicative of cartilage still remaining injoint). The patients had also not undergone within 3 months ofenrollment, corticosteroid or viscosupplementation (i.e., hyaluronate)injections to the effected knee. Further, the patient had not been on astable dose for at least 3 months prior to enrollment of oral steroids,non-steroidal anti-inflammatories, or acetaminophen. If takingchondroprotective supplements (e.g., glucosamine and chondroitinsulfate), patient had not been on a stable dose for at least 3 monthsprior of enrollment. Table 1 summarizes the patient population:

TABLE 1 Patient Summary No. Side Age KL (PF) KL (FT) Extension Flexioncase 1 Lt 73 3 2 −10 115 case 2 Lt 73 3 2 −20 135 case 3 Rt 73 3 2 −5135 case 4 Lt 62 2 2 0 140 case 5 Lt 62 1 2 −5 140 PatternedNeuromuscular Simulation for 20 min 3 times/week × 12 weeks

Each patient received a 20-minute session, to each affected knee, threetimes per week for 12 weeks. The neuromuscular electrical stimulationcomprised a tri-phasic lower extremity stimulation pattern based onactivation timing of the quadriceps and hamstrings for strengthtraining. More specifically, the patient received 50 Hz impulses for 200ms every 1500 ms) to establish a minimal twitch for 5 minutes and amoderate to strong, but well-tolerated twitch contractions for 15minutes. The overlap period was 40 ms. The electrodes were placed on thepatient as generally shown in FIG. 3P. The first pair of electrodes arepositioned on the patient's skin on the vastus medialis and upperquadricep, and the second pair is positioned on the hamstring andtriceps Surae muscles. Even though the exact mechanism of action forpotential improvement of knee osteoarthritis and joint compression isnot fully understood, it is hypothesized that when stimulating themuscles in this region that there may be an effect on changing thecirculation of the synovial fluid, an effect on reducing disuse atrophyof the quadriceps and hamstrings, and an improvement in motor timing.The maximum peak output of the device is 10 mA into a 500 ohm load. Theaverage current is very low because the pulse duration is only 70microseconds at a pulse rate of 50 Hz. The average current would beapproximately 4.5 mA average current into a 500 ohm load. The typicaloutputs used in stimulation varied from approximately 30-70 mA peakcurrent or 1-3 mA average current.

FIG. 7A shows the Visual Analog Scores of the five patients over thetreatment period on a 0 to 100 mm scale. In general, the patients' painlevel increased (FIG. 7A), while their overall condition improved (FIG.7B). The scale was be anchored at one end with “0” and labeled “no painat all,” and at the other “10” and labeled “worst pain possible.” FIG. 8illustrates the results of the Western Ontario MacMaster 3.1 (WOMAC), a24-item validated test designed specifically for the assessment of lowerextremity pain, stiffness, and physical function disability inosteoarthritis of the knee. WOMAC scores were very much higher(abnormal) prior to undergoing treatment.

FIGS. 9 and 10 show the muscle strength of each patient throughout thecourse of treatment for the quadriceps, and hamstrings respectively. Thestrength of patients 1 and 2 was measured in Newtons, while that ofpatients 3, 4, and 5 was measured in kilograms. In general, the musclestrength improved over the course of treatment. The muscle strength wasmeasured using a mechanical dynamometer.

The immediate effect of a 20-minute treatment was also evaluated using aphysical performance test. Patients were asked to stand up 10 times asfast as possible. FIG. 11A that the patient's VAS pain level decreasedafter most treatment sessions. Further, as shown in FIG. 11B, the amountof time it took to complete the test either decreased or was not changedas a result of the treatment session. As shown in FIG. 11C, over theentire 24-week treatment course, the amount of time it took it took tocomplete the test generally decreased.

The amount of fluid in the affected knee of each patient was alsomeasured in order to assess the degree of inflammation in the joint. Asshown in Table 2, in four of the five patients, the amount of fluid inthe joint decreased by amount 2 ml. Thus, this indicates that theneuromuscular electrical stimulation was effective in decreasinginflammation.

TABLE 2 Joint Fluid Joint Fluid Post 12 Joint Fluid weeks of No. Pre mltreatment Case 1 2 0 Case 2 12 10 Case 3 0 N/A Case 4 2 0 Case 5 7 10

Lastly, delayed gadolinium-enhanced magnetic resonance imaging (“MRI”)of cartilage (“dGEMRIC”) was used in order to is used to examine thedistribution of glycosaminoglycan in cartilage as generally described inWilliams et al., Delayed gadolinium-enhanced magnetic resonance imagingof cartilage in knee osteoarthritis: findings at different radiographicstages of disease and relationship to malalignment, Arthritis Rheum.2005 November; 52(11):3528-35, which is incorporated by reference.Glycosaminoglycans provide cartilage its compressive strength and thedGEMRIC technique uses a negatively charged MR contrast agent todetermine the GAG distribution within the cartilage. Table 3 below showsthat the relative intensity of the tibia and femur generally decreased.A negative pre-post reading indicates increased markers for cartilage.

TABLE 3 Relative intensity Tibia Femur Pre Post Pre Post Case 1 67.262.2 −7.44% 76.4 72.8 −4.71% Case 2 60.7 64.5  6.26% 73.4 72.5 −1.22%Case 3 80.9 73.5 −9.15% 73.3 84.2  14.9% Case 4 72.3 56.1 −22.4% 85.886.8  1.17% Case 5 109 100 −8.26% 88.4 98  10.9%

Together, these experiments indicate that joint compression decreasedafter applying the patterned neuromuscular electrical stimulation to theaffected joint.

While specific embodiments have been shown and discussed, variousmodifications may of course be made, and the invention is not limited tothe specific forms or arrangement of parts and steps described herein,except insofar as such limitations are included in the following claims.Further, it will be understood that certain features and subcombinationsare of utility and may be employed without reference to other featuresand subcombinations. This is contemplated by and is within the scope ofthe claims.

What is claimed and desired to be secured by Letters Patent is asfollows:
 1. A method for reducing joint compression caused byco-contraction of antagonist and agonist muscles in a patient in needthereof, comprising: applying neuromuscular electrical stimulationhaving a biphasic or triphasic pulse train pattern to at least twomuscles associated with a target joint in said patient; and wherein saidstep of applying neuromuscular stimulation decreases co-contraction ofsaid at least two muscles after said applying step.
 2. The method ofclaim 1, wherein said step of applying neuromuscular electricalstimulation having a biphasic or triphasic pulse train patterncomprises: providing a first channel comprising two electrodes, whereina first electrode of said first channel is positioned in electricalcontact with tissue of a first muscle of said target joint of saidpatient and a second electrode of said first channel is positioned inelectrical contact with tissue of said first muscle or a second muscleof said target joint of said patient; providing a second channelcomprising two electrodes, wherein a first electrode of said secondchannel is positioned in electrical contact with tissue of said secondmuscle or a third muscle of said target joint of said patient and asecond electrode of said second channel is positioned in electricalcontact with tissue of said second muscle, third muscle or a fourthmuscle of said target joint of said patient; and applying a series ofelectrical pulses having said biphasic or triphasic pulse train patternto said target joint of said patient through said first and secondchannels in accordance with said procedure for reducing said jointcompression.
 3. The method of claim 2, wherein said first electrode ofsaid first channel is positioned so as to stimulate a trapezius muscleof said patient, and said second electrode of said first channel ispositioned so as to stimulate a cervical paraspinal muscle of saidpatient; and wherein said first and second electrodes of said secondchannel are positioned bilaterally so as to stimulate a second trapeziusmuscle and a second cervical paraspinal muscle of said patient.
 4. Themethod of claim 2, wherein said first electrode of said first channel ispositioned so as to stimulate a lower cervical paraspinal muscle and anupper thoracic paraspinal muscle of said patient, and said secondelectrode of said first channel is positioned so as to stimulate acervical paraspinal muscle of said patient; and wherein said first andsecond electrodes of said second channel are positioned bilaterally soas to stimulate a second lower cervical paraspinal muscle, a secondupper thoracic paraspinal muscle, and a second cervical paraspinalmuscle of said patient.
 5. The method of claim 2, wherein said firstelectrode of said first channel is positioned so as to stimulate athoracic paraspinal muscle of said patient, and said second electrode ofsaid first channel is positioned so as to stimulate an upper thoracicparaspinal muscle of said patient; and wherein said first and secondelectrodes of said second channel are positioned bilaterally so as tostimulate a second thoracic paraspinal muscle and a second upperthoracic paraspinal muscle of said patient.
 6. The method of claim 2,wherein said first electrode of said first channel is positioned so asto stimulate a thoracic and/or lumbar paraspinal muscle of said patient,and said second electrode of said first channel is positioned so as tostimulate an abdominal muscle of said patient; and wherein said firstand second electrodes of said second channel are positioned bilaterallyso as to stimulate a second thoracic and/or lumbar paraspinal muscle anda second abdominal muscle of said patient.
 7. The method of claim 2,wherein said first and second channels each further comprise a thirdelectrode and a fourth electrode; wherein said first and secondelectrodes of said first channel are positioned so as to stimulate amultifidus muscle of said patient, and said third and fourth electrodesof said first channel are positioned so as to stimulate an abdominalmuscle of said patient; and wherein said first, second, third, andfourth electrodes of said second channel are positioned bilaterally soas to stimulate a second multifidus muscle and a second abdominal muscleof said patient.
 8. The method of claim 2, wherein said first and secondelectrodes of said first channel are positioned so as to stimulate abiceps brachii muscle of said patient; and wherein said first and secondelectrodes of said second channel are positioned so as to stimulate atriceps brachii muscle of said patient.
 9. The method of claim 2,wherein said first electrode of said first channel is positioned so asto stimulate a biceps brachii muscle of said patient, and said secondelectrode of said first channel is positioned so as to stimulate apectoralis major muscle and an anterior deltoid muscle of said patient;and wherein said first electrode of said second channel is positioned soas to stimulate a triceps brachii muscle of said patient, and saidsecond electrode of said second channel is positioned so as to stimulatean infraspinatus teres minor muscle and a posterior deltoid muscle ofsaid patient.
 10. The method of claim 2, wherein said first electrode ofsaid first channel is positioned so as to stimulate a biceps brachiimuscle of said patient, and said second electrode of said first channelis positioned so as to stimulate an anterior deltoid muscle of saidpatient; and wherein said first electrode of said second channel ispositioned so as to stimulate a triceps brachii muscle of said patient,and said second electrode of said second channel is positioned so as tostimulate a posterior deltoid muscle of said patient.
 11. The method ofclaim 2, wherein said first electrode of said first channel ispositioned so as to stimulate a flexor muscle of a hand of said patientselected from a group consisting of flexor digitorum superficialis andflexor digitorum profundus, and said second electrode of said firstchannel is positioned so as to stimulate a flexor muscle of a wrist ofsaid patient selected from the group consisting of flexor carpi ulnarisand flexor carpi radialis; and wherein said first electrode of saidsecond channel is positioned so as to stimulate an extensor muscle ofsaid hand of said patient selected from the group consisting of extensordigitorum and extensor digiti minimi, and said second electrode of saidsecond channel is positioned so as to stimulate an extensor muscle ofsaid wrist of said patient selected from the group consisting ofextensor carpi ulnaris and extensor carpi radialis.
 12. The method ofclaim 2, wherein said first electrode of said first channel ispositioned so as to stimulate a flexor muscle of a hand of said patient,and said second electrode of said first channel is positioned so as tostimulate a biceps brachii muscle of said patient; and wherein saidfirst electrode of said second channel is positioned so as to stimulatean extensor forearm muscle of said patient, and said second electrode ofsaid second channel is positioned so as to stimulate a triceps brachiimuscle of said patient.
 13. The method of claim 2, wherein said firstelectrode of said first channel is positioned so as to stimulate anextensor digitorum brevis muscle of said patient, and said secondelectrode of said first channel is positioned so as to stimulate atibialis anterior muscle, an extensor digitorum longus muscle, and/or anextensor hallucis longus muscle of said patient; and wherein said firstelectrode of said second channel is positioned so as to stimulate anintrinsic foot muscle of said patient, and said second electrode of saidsecond channel is positioned so as to stimulate a posterior tibialismuscle and a flexor hallucis muscle of said patient.
 14. The method ofclaim 2, wherein said first and second electrodes of said first channelare positioned so as to stimulate a tibialis anterior muscle and anoptional peroneus muscle of said patient; and wherein said first andsecond electrodes of said second channel are positioned so as tostimulate a triceps surae of said patient.
 15. The method of claim 2,wherein said first electrode of said first channel is positioned so asto stimulate a tibialis anterior muscle of said patient, and said secondelectrode of said first channel is positioned so as to stimulate aquadriceps muscle of a leg of said patient; and wherein said firstelectrode of said second channel is positioned so as to stimulate atriceps surae of said patient, and said second electrode of said secondchannel is positioned so as to stimulate a hamstring muscle of said legof said patient.
 16. The method of claim 2, wherein said first electrodeof said first channel is positioned so as to stimulate a vastus medialismuscle of said patient, and said second electrode of said first channelis positioned so as to stimulate a gluteus medius muscle, a gluteusminimus muscle, and a tensor fasciae latae muscle of said patient; andwherein said first electrode of said second channel is positioned so asto stimulate a biceps femoris muscle, a semitendinosus muscle, and/or asemimembraneous muscle of said patient, and said second electrode ofsaid second channel is positioned so as to stimulate an adductor magnusmuscle, an adductor longus muscle, an adductor brevis muscle, and amedial hamstring muscle of said patient.
 17. The method of claim 2,wherein said first electrode of said first channel is positioned so asto stimulate a rectus femoris muscle and/or a vastus lateralis muscle ofsaid patient, and said second electrode of said first channel ispositioned so as to stimulate a vastus medialis muscle of said patient;and wherein said first and second electrodes of said second channel arepositioned so as to stimulate a biceps femoris muscle, a semimembranosusmuscle, and/or a semitendinosus muscle of said leg of said patient. 18.The method of claim 1, wherein said decreased co-contraction isdetermined using EMG.
 19. The method of claim 1, wherein said decreasedco-contraction is determined using a tissue hardness and tissuecompliance measuring system.
 20. The method of claim 1, furthercomprising a step of co-administering said electrical stimulation tosaid patient and a therapeutically effective amount of an agent selectedfrom a group consisting of nonsteroidal anti-inflammatory drugs (NSAIDS)or analgesics; tramadol; codeine; propoxyphene; glucosamine; chondroitinsulfate; salicylates; Cox-2 NSAIDS; surface application of capsaicincream 0.25%; steroids, corticosteroids, or hyaluronic acid preparations.21. The method of claim 2, wherein said series of electrical pulsescomprises a plurality of cycles of a biphasic sequential pulse trainpattern; and wherein said biphasic sequential pulse train patterncomprises a first phase of electrical pulses applied to said firstchannel and a second phase of electrical pulses applied to said secondchannel, and wherein said second phase of electrical pulses commencesafter termination of said first phase of electrical pulses.
 22. Themethod of claim 2, wherein said series of electrical pulses comprises aplurality of cycles of a biphasic overlapping pulse train pattern; andwherein said biphasic overlapping pulse train pattern comprises a firstphase of electrical pulses applied to said first channel and a secondphase of electrical pulses applied to said second channel, and whereinsaid second phase of electrical pulses commences before termination ofsaid first phase of electrical pulses.
 23. The method of claim 2,wherein said series of electrical pulses comprises a plurality of cyclesof a triphasic sequential pulse train pattern; wherein said triphasicsequential pulse train pattern comprises a first phase of electricalpulses applied to said first channel, a second phase of electricalpulses applied to said second channel, and a third phase of electricalpulses applied to said first channel; and wherein said second phase ofelectrical pulses commences after termination of said first phase ofelectrical pulses and said third phase of electrical pulses commencesafter termination of said second phase of electrical pulses.
 24. Themethod of claim 2, wherein said series of electrical pulses comprises aplurality of cycles of a triphasic overlapping pulse train pattern;wherein said triphasic overlapping pulse train pattern comprises a firstphase of electrical pulses applied to said first channel, a second phaseof electrical pulses applied to said second channel, and a third phaseof electrical pulses applied to said first channel; and wherein saidsecond phase of electrical pulses commences before termination of saidfirst phase of electrical pulses and said third phase of electricalpulses commences before termination of said second phase of electricalpulses.
 25. The method of claim 1, wherein a delay between each saidpulse train pattern is between 400 milliseconds and 1200 milliseconds.26. The method of claim 1 wherein said decreased co-contraction ismeasured by a decrease in the I-EMG in said at least two target musclesof said patient at rest or at a predetermined load.
 27. The method ofclaim 1 wherein said decreased co-contraction is measured by a decreasein the FFT in said at least two target muscles of said patient at restor at a predetermined load.
 28. The method of claim 1 wherein saiddecreased co-contraction is measured by a decrease in the hardness ofsaid at least two target muscles using a tissue hardness and tissuecompliance measurement system.
 29. The method of claim 2, wherein saidfirst electrode of said first channel is positioned so as to stimulatean upper quadricep muscle of said patient, and said second electrode ofsaid first channel is positioned so as to stimulate a vastus medialismuscle of said patient; and wherein said first electrode of said secondchannel is positioned so as to stimulate a hamstring muscle of saidpatient, and said second electrode of said second channel is positionedso as to stimulate a triceps surae muscle of said patient.